The planned project will ask the question, what was the historical process by which the conventions of the randomized clinical trial (RCT) were developed into a fully defined methodology and accepted by U.S. policy makers and the American scientific community as the "gold standard" for the evaluation of the effectiveness of medical products and procedures? There are two phases of the project: first, an investigation of the internal process by which the FDA gave the RCT official regulatory status in 1969; secondly, a review of carefully selected specific trials of the 1950s and 1960s and the negotiation process which framed their planning and implementation. The hypothesis of the study is that the RCT is not a static dogma, but a dynamic tool, which was crafted and adapted for use in a specific American historical context, and has been further modified and redesigned to meet changing medical and social needs within its history. This reconsideration of the RCT should offer productive insights into its future application as a measure of medical effectiveness.